Evaluation of Stone Composition in Surgical Kidney Stone Patients in Vietnam

Completed

• Conditions: Kidney Stones; Urolithiasis; Nephrolithiasis

• Registration Number: NCT07038954
• Lead Sponsor: Binh Dan Hospital

Brief Summary

This is a prospective observational study conducted at Binh Dan Hospital, Ho Chi Minh City, Vietnam, from July to December 2023. The study aims to analyze the composition of kidney stones in patients undergoing surgical interventions such as percutaneous nephrolithotomy (PCNL), ureteroscopic lithotripsy, laparoscopic ureterolithotomy, or open surgery. Stone fragments collected during the procedures were analyzed using X-ray diffraction (XRD) and infrared spectroscopy (IR).

The primary goal of this study is to identify the types and distribution of kidney stone compositions in a Vietnamese surgical cohort and compare them with global patterns. Findings from this study are expected to provide insights into age- and gender-related differences in stone composition, and contribute to improved prevention strategies for recurrent urolithiasis.

The study was approved by the Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City. All participants provided written informed consent.

Detailed Description

Kidney stone disease (urolithiasis) is a common and recurrent condition worldwide. Vietnam is located in a high-incidence zone known as the "stone belt." Understanding the composition of kidney stones is essential for guiding treatment decisions and implementing effective preventive strategies. Although surgical treatment options have advanced, stone recurrence remains a significant concern. However, there is currently limited data in Vietnam regarding the composition of stones in patients undergoing surgical management.

This prospective observational study is being conducted at the Department of Urology, Binh Dan Hospital, Ho Chi Minh City, Vietnam. The study period is from July to December 2023. Eligible participants include patients aged 15 years and older undergoing surgical stone removal via one of the following procedures: percutaneous nephrolithotomy (PCNL), semirigid ureteroscopic lithotripsy, laparoscopic ureterolithotomy, or open surgery. Patients with missing or unsuitable stone samples, incomplete clinical data, or contraindications to surgery are excluded.

During surgery, retrieved stone fragments are collected for analysis. Stone composition is analyzed using both X-ray diffraction (XRD) and infrared spectroscopy (IR), which are reliable methods for identifying stone components. The analysis focuses on determining the presence of calcium oxalate (monohydrate and dihydrate), phosphate (hydroxyapatite and brushite), uric acid, infection-related stones (struvite and ammonium hydrogen urate), and cystine stones.

This study has received ethical approval from the Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 22441-DHYD). All participants provide written informed consent prior to enrollment. The study is funded by the Department of Science and Technology of Ho Chi Minh City as part of a provincial-level research initiative, with additional institutional support from Binh Dan Hospital and the University of Medicine and Pharmacy at Ho Chi Minh City.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• Patients aged 15 years and older.
• Diagnosed with kidney or ureteral stones requiring surgical intervention.
• Underwent PCNL, URS, laparoscopic ureterolithotomy, or open stone surgery.
• Provided written informed consent.

Exclusion Criteria

• Patients with missing or unsuitable stone samples.
• Patients with incomplete clinical data.
• Patients with contraindications to surgery.
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of stone types in surgically treated kidney stone patients	Within 1 month after surgical stone removal	Determination of the proportion of each major stone type (calcium oxalate, phosphate, uric acid, struvite, and cystine) using X-ray diffraction (XRD) and infrared spectroscopy (IR).

Trial Locations

Locations (1)

Binh Dan Hospital; 🇻🇳 Ho Chi Minh City, Ho Chi Minh, Vietnam